Atossa Therapeutics Contracts for Clinical Study of AT-301 Nasal Spray, Atossa’s Second COVID-19 Therapeutic Development Pr...
July 16 2020 - 09:15AM
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage
biopharmaceutical company seeking to discover and develop
innovative medicines in areas of significant unmet medical need
with a current focus on breast cancer and COVID-19, announced that
it has contracted with Avance Clinical Pty Ltd to conduct a
clinical study of Atossa’s proprietary drug candidate AT-301, to be
administered by nasal spray. Avance is a leading Australian
clinical research organization and has successfully completed
multiple clinical studies of Atossa’s proprietary Endoxifen.
AT-301 is Atossa’s proprietary formula intended
for nasal administration in patients immediately following
diagnosis of COVID-19 but who have not yet exhibited symptoms
severe enough to require hospitalization. It is intended for
at-home use to proactively reduce symptoms of COVID-19 and to slow
the infection rate so that a person’s immune system can more
effectively fight SARS-CoV-2 (coronavirus). Atossa also intends to
conduct testing to determine whether AT-301 can be used as a
prophylaxis to prevent or mitigate SARS-CoV-2.
The study is a double-blinded, randomized, and
placebo-controlled safety study of AT-301 nasal spray in 32 healthy
adult subjects divided into two study groups. Part A consists of
two single-dose cohorts receiving either active therapy, AT-301B,
or the placebo comparator AT-301A. Part B is a multiple dose arm
with cohorts receiving either AT-301A or AT-301B for 14 days. The
primary objective of the study is to evaluate the safety and
tolerability of single and multiple doses of AT-301 administered
via nasal instillation to healthy volunteers. Secondary objectives
are to assess the incidence and severity of local irritation and
bronchospasm following administration of AT-301 via nasal
instillation. “Our AT-301 nasal spray program is being developed
for COVID-19 patients who are not hospitalized, which complements
our AT-H201 program being developed for COVID-19 patients on
ventilators,” commented Steven Quay, M.D., Ph.D., President and CEO
of Atossa. “Many COVID-19 patients are infected via the nasal
passage, which makes a nasal spray therapy potentially very
attractive. Collectively, the components of AT-301 are believed to
replicate a ‘vaccine-like mechanism’ to help maintain a protective
mucosal barrier within the nasal cavity with anti-viral properties
that may lead to lower infectivity and reduced symptoms in COVID-19
patients due to their interference with the spike protein of the
virus in the nasal cavity and upper respiratory tract. We may
eventually develop AT-301 as a prophylaxis to reduce risk of being
infected with COVID-19. For example, it could be taken as a daily
vaccine-like treatment for people at higher-risk, such as TSA
workers, emergency medical professionals and hospital personnel,”
concluded Dr. Quay.An application to commence the study has been
submitted to the relevant institutional review board (IRB) and
local regulatory authority in Australia which must be approved
before commencement of the study. Pending these approvals, Atossa
expects that the study will commence this quarter.Adequate and
well-controlled studies to demonstrate safety and efficacy must be
successfully completed and regulatory approvals must be obtained
before AT-301 may be commercialized. Atossa has filed provisional
patent applications on AT-301 to treat patients diagnosed with, or
to prevent, COVID-19 via nasal spray.ABOUT ATOSSA
THERAPEUTICSAtossa Therapeutics, Inc. is a clinical-stage
biopharmaceutical company seeking to discover and develop
innovative medicines in areas of significant unmet medical need
with a current focus on breast cancer and COVID-19. For more
information, please visit www.atossatherapeutics.com.ABOUT
AVANCE CLINICAL PTY LTDAvance Clinical Pty Ltd is a
leading Australian CRO with a client portfolio that extends
across North America, Canada, New Zealand, Asia and
Europe. Avance Clinical is an Australian owned CRO that has
been providing high-quality clinical research services to the local
and international drug development industry for 20 years. Its
office is located in Adelaide, South Australia with employees
operating across the major Australian states and New Zealand.
Avance Clinical specializes in working with biotech companies to
execute Phase 1 and Phase 2 clinical trials. It is a full service
CRO with services including clinical project management, clinical
trial monitoring, drug safety reporting, medical writing, data
management, statistical and pharmacokinetic services, and external
auditing. FORWARD-LOOKING STATEMENTS
Forward-looking statements in this press
release, which Atossa undertakes no obligation to update, are
subject to risks and uncertainties that may cause actual results to
differ materially from the anticipated or estimated future results,
including the risks and uncertainties associated with the
following: whether in vitro test results will also be
achieved in in vivo studies, including human clinical
studies, actions by and interactions with the FDA, the outcome or
timing of regulatory approvals needed by Atossa including those
needed to commence human clinical studies of AT-301 and the outcome
of such trials, lower than anticipated rate of patient enrollment,
the safety and efficacy of Atossa’s product candidates, performance
of developers and manufacturers, clinical research organizations
and investigators, obstacles resulting from proprietary rights held
by others such as patent rights, uncertainties affecting our
ability to secure patent protection for AT-301 or AT-H201 and other
risks detailed from time to time in Atossa’s filings with the
Securities and Exchange Commission, including without limitation
its periodic reports on Form 10-K and 10-Q, each as amended and
supplemented from time to time.Company Contact: Atossa
Therapeutics, Inc. Kyle Guse, CFO and General Counsel Office: (866)
893-4927 kyle.guse@atossainc.comInvestor Relations Contact: Core IR
Office: (516) 222-2560 ir@atossainc.com Source: Atossa
Therapeutics, Inc.
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